FDA applicant
Health Beacons, Inc.
FDA records 4 decisions for Health Beacons, Inc. (Concord, MA) from 2017 to 2020: 4 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and PBY (Temporary Tissue Marker). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Health Beacons, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Health Beacons, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report